BMS Submits sBLA for Two Opdivo-Based Immune Combination Therapies as First-Line Treatment for Esophageal Squamous Cell Carcinoma

On September 27, 2021, Bristol Myers Squibb announced that, based on positive results from a Phase 3 clinical trial, the U.S. FDA has accepted its supplemental Biologics License Application (sBLA) for a dual immunotherapy comprising the PD-1 inhibitor nivolumab and the CTLA-4 inhibitor ipilimumab, as well as for a combination therapy of nivolumab plus fluorouracil and platinum-based chemotherapy, for the first-line treatment of advanced unresectable, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).

Nivolumab (brand name: Opdivo) targets and inhibits PD-1, helping to restore the body's anti-tumor immune response. Ipilimumab (brand name: Yervoy) targets and inhibits CTLA-4. CTLA-4 antibodies enhance tumor-killing capacity by boosting T-cell activity. This product is the world's first CTLA-4 antibody drug to be approved and marketed.

This application is based on the results of a pivotal Phase 3 clinical trial, with the primary endpoints of overall survival (OS) and progression-free survival (PFS). The trial demonstrated that, in patients with advanced unresectable/metastatic esophageal squamous cell carcinoma (ESCC) with tumor PD-L1 expression ≥1%, as well as in the all-randomized population, both nivolumab plus ipilimumab and nivolumab plus chemotherapy demonstrated statistically and clinically significant overall survival (OS) benefits compared with the chemotherapy control group. The press release noted that the nivolumab/ipilimumab combination is the first dual immunotherapy regimen to demonstrate a survival benefit superior to chemotherapy in this patient population. Furthermore, the safety profiles of the combination therapies were consistent with those of the individual monotherapies.

Esophageal cancer is the eighth most common cancer and the sixth leading cause of cancer death worldwide, with approximately 600,000 new cases and over 540,000 deaths in 2020. The most common types of esophageal cancer are squamous cell carcinoma and adenocarcinoma, accounting for approximately 85% and 15% of all cases, respectively.

References:

[1] U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Applications for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + Chemotherapy for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma.Retrieved September 27, 2021, from https://www.businesswire.com/news/home/20210927005391/en/

(Original text abridged)

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